Neoadjuvant Pegylated Liposomal Doxorubicin and Cyclophosphamide +/- Trastuzumab Followed by Docetaxel in Breast Cancer

Phase 2

Completed

• Conditions: Breast Cancer

• Registration Number: NCT01206881
• Lead Sponsor: Herlev Hospital

Brief Summary

The purpose of this study is to determine the efficacy of neoadjuvant treatment with pegylated liposomal doxorubicin (Caelyx) and cyclophosphamide +/- trastuzumab followed by docetaxel in patients with locally advanced, inflammatory breast cancer or with a primary tumor \> 5 cm.

Detailed Description

Patients with locally advanced or inflammatory breast cancer have a very bad prognosis. Several studies have shown that patients who receive a pathological complete response have the best prognosis. Neoadjuvant chemotherapy including anthracyclines and taxanes has become established as a standard option in the multidisciplinary management of this group of patients. In HER2 positive patients, chemotherapy in combination with trastuzumab is therapeutically attractive. Recent studies have also demonstrated that evaluation with PET-CT scan can be used to stratify treatment and monitor early response to neoadjuvant therapy.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2010-09-13
• Study First Submitted QC: 2010-09-21
• Study First Posted: 2010-09-22
• Primary Completion: 2011-05
• Status Verified: 2011-06
• Study Completion: 2011-06
• Last Update Submitted: 2011-06-30
• Last Update Posted: 2011-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 45

Inclusion Criteria

• pathologically proven breast cancer
• inflammatory, locally advanced breast cancer or a tumor > 5 cm
• ECOG performance status < 2
• LVEF > 50% measured by MUGA (HER2 positive patients)
• adequate bone marrow, liver and renal function
• written informed consent must be obtained

Exclusion Criteria

• another malignancy within 5 years prior to study entry
• concurrent treatment with an investigational agent
• other disease or condition that contraindicates participation in the study
• pregnant or lactating females

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
clinical response rate	24 weeks	evaluation of treatment efficacy every 2.cycle

Secondary Outcome Measures

Name	Time	Method
pathological response rate, response rate as defined by PET-CT scan, mammography and ultrasound, evaluation of toxicity of the combination regimen	up to 30 weeks

Trial Locations

Locations (4)

Herlev Hospital; 🇩🇰 Herlev, Denmark

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark